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    The EU Clinical Trials Register currently displays   38965   clinical trials with a EudraCT protocol, of which   6398   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
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    EudraCT Number:2010-019428-30
    Sponsor's Protocol Code Number:D1680L00006
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-06-25
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2010-019428-30
    A.3Full title of the trial
    A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IIIb tudy to Evaluate the Efficacy and Safety of Saxagliptin in Combination with Metformin and Sulfonylurea in Subjects with Type 2 Diabetes who have Inadequate Glycaemic control with the Combination of Metformin and Sulfonylurea
    A.4.1Sponsor's protocol code numberD1680L00006
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstraZeneca Singapore Pte Ltd
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namesaxagliptin
    D.3.2Product code BMS-477118-11
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsaxagliptin
    D.3.9.1CAS number 945667-22-1
    D.3.9.2Current sponsor codeBMS-477118-11
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Type 2 diabetes mellitus
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 diabetes mellitus
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary efficacy analysis is to compare the difference between saxagliptin 5 mg od plus metformin plus sulfonylurea versus placebo plus metformin plus sulfonylurea, in patients with type 2 diabetes, as determined by the change in HbA1c levels from Baseline to Week 24/Endpoint.
    E.2.2Secondary objectives of the trial
    Compare change in fasting plasma glucose (FPG) from Baseline to Week 24/Endpoint between the treatment groups.
    Compare change in postprandial glucose (PPG) (measured 2 hours after breakfast) from Baseline to Week 24/Endpoint between the treatment groups;
    Compare proportion of patients achieving a therapeutic glycaemic response at Week 24/Endpoint defined as HbA1c <7% between the treatment groups.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of written informed consent prior to the performance of any study-related procedures.

    2.Males and females who are ≥18 years of age at the time of obtaining consent at Visit 1.

    3.Clinical diagnosis of type 2 diabetes with uncontrolled glycaemia in spite of being on the combination of metformin IR or XR (MTD, minimum dose for enrolment being 1500 mg) plus sulfonylurea (at MTD, with minimum dose for enrolment being ≥50% of the maximum recommended dose) daily, for at least 8 weeks prior to Visit 1.

    4. HbA1c ≥7% and ≤10% obtained at Visit 1 as confirmed by the central laboratory.

    5.BMI ≤40 kg/m2.

    6.Females of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimised and have a negative urine preganancy test at Visit 2 and each scheduled study visit thereafter.
    Definitions: - Females of Child Bearing Potential - women who have experienced menarche but who have not been permanently or surgically sterilised, are not postmenopausal and are capable of procreation. - Females NOT of Child Bearing Potential - women who have undergone successful surgical sterilisation (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or who are postmenopausal. - Postmenopausal Women - women will be considered postmenopausal if they have had amenorrhea > or = 12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level >35 mIU/ml.

    E.4Principal exclusion criteria
    1.Any clinically significant abnormality identified on physical examination or laboratory tests that would compromise patient’s safety or successful participation in the study as judged by the investigator.

    2.Pregnant or breastfeeding females.

    3.Symptoms of poorly controlled diabetes including but not limited to marked polyuria and polydipsia with more than 10% weight loss in the 3 months before Visit 1 or other signs and symptoms.

    4.History of diabetic ketoacidosis or hyperosmolar non-ketotic coma.

    5.Current or prior use within 3 months of Visit 1, of insulin, DPP4 inhibitor, GLP-1 analogues (exenatide or liraglutide), and/or other oral anti-diabetic agents (other than metformin and sulfonylurea).

    6.Estimated CrCl <60 ml/min at Visit 2.

    7.Congestive heart failure defined as New York Heart association (NYHA) class III or IV (see Appendix D) and/or left ventricular ejection fraction of <40%.

    8.Active liver disease and/or significant abnormal liver function define as aspartate aminotransferase (AST) >3 x the upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3 x ULN and/or bilirubin >2.0 mg/dL (> 34 µmol) at Visit 2.

    9.Creatine kinase ≥10 x ULN at Visit 2.

    10.Treatment with systemic glucocorticoids other than replacement therapy. Inhaled, local injected and topical use of glucocorticoids is allowed.

    11.Treatment with CYP3A4 inducers, such as carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampin and St. John’s Wort, and/or potent CYP3A4/5 inhibitors, such as delavirdine, indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole (topical use is allowed), nefazodone, saquinavir and telithromycin.

    12.Patients who could have a potential allergy to the investigational product or any of its formulation excipients.

    13.Contraindications to therapy as outlined in the metformin and/or sulfonylurea package insert including conditions leading to an increased risk of hypoxemia and lactic acidosis.

    14.History of haemoglobinopathies (sickle cell anaemia or thalassemias, sideroblastic anaemia).

    15.History of alcohol abuse or illegal drug abuse within the past 12 months prior to Visit 1.

    16.Involvement in the planning and conduct of the study (applies to both AstraZeneca and Bristol-Myers Squibb personnel or personnel at the study centre).

    17.Participation in an interventional clinical study during the 30 days prior to Visit 1.

    18.Donation of blood, plasma or platelets within the 3 months prior to Visit 1.

    19.Individuals, in the opinion of the investigator, whose participation in this
    study may pose a significant risk to the patient and could render the patient unable to successfully complete the study.

    20.Suspected or confirmed poor protocol or medication compliance as judged by the investigator.

    21.Previous enrolment or randomisation in the present study.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint is change in HbA1c from Baseline to Week 24/Endpoint.

    Secondary endpoints are Change in FPG from Baseline to Week 24/Endpoint, change in PPG (measured 2 hours after breakfast) from Baseline to Week 24/Endpoint and proportion of patients achieving a therapeutic glycaemic response at Week 24/Endpoint defined as HbA1c <7%
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned12
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days13
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days13
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 275
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2010-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-05-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-06-14
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